# K111323: Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants

- Pathway: 510(k) (Traditional)
- Applicant: Synthes, Inc.
- Decided: Nov 16, 2011 after 189 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K791495 (1979). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080507: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Ceremed, Inc. (2008) Summary page 1.

## Most influential descendants
- K133809: Osteofab Patient Specific Facial Device (2014), 1 descendant of its own
- K161052: OsteoFab Patient Specific Facial Device (2016), 0 descendants of its own

## Indications for use
Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. Specific indications (SynPOR HD Ocular Spheres): * Ocular reconstruction * Socket preservation Specific indications (SynPOR HD Facial Shapes): * Enhancement of the malar and chin * Correction of deficiencies of the malar and chin

Source page: https://510kreport.com/device/K111323
Methodology: https://510kreport.com/methodology